Shares of Aurinia Pharmaceuticals Inc. (AUPH) saw a handy gain on Friday after the company announced plans for the development of a late-stage trial. Specifically, Aurinia conducted discussions with the European Medicines Agency (EMA) and the Pharmaceutical and Medical Devices Agency (PMDA) in Japan regarding the development of voclosporin for the treatment of active lupus nephritis (LN).
The company walked away from these discussions feeling fairly positive about the outcome of this trial. Aurinia believes that the confirmatory data that can be generated from the single Phase 3 clinical trial (AURORA) and the recently completed AURA-LV (AURA) Phase 2b study should support regulatory submissions in the United States, Europe and Japan.
The Phase 3 AURORA trial will be a global 52-week double-blind, placebo controlled study of roughly 320 patients.
Lawrence D. Mandt, Vice President of Quality and Regulatory Affairs at Aurinia, commented:
Our interactions with regulators in all three jurisdictions have given us a clear pathway for Phase III, and we are confident in our ability to execute AURORA successfully based on their feedback and the information gleaned from the AURA study. The productive conclusion of these regulatory interactions marks a milestone in our development program and brings this exciting new therapeutic option one step closer to those patients suffering from LN.
So far in 2017, Aurinia shares have absolutely exploded. The stock is up roughly 244% year to date. However, over the past 52 weeks the stock is up only 153%.
Shares of Aurinia were last seen up 9% to $7.21 on Friday, with a consensus analyst price target of $10.70 and a 52-week trading range of $1.74 to $10.54.